Test Description Result Prognostic Interpretation …

1 HER2 scoring criteria update for breast CancerASCO/CAP has recently released revised scoring criteria for HER2 analysis ( fish and IHC) for breast cancer . GenPath would like to advise you of the report changes we have made (see below) to reflect these HER2 scoring changes. Revised HER2 Guidelines available online through CAP. UpdateIf you have any questions please contact your local sales representativeThank YouFinal Report SMITH, SUSAN ONCOLOGY CENTER 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 F: 555-555-5555 DOCTORPATIENTSAMPLESAMPLE, REPORT DOB: 11/19/1956 Age: 56Y Sex: F Surgical #: XXXXXXXX Patient ID: 55555555 Address: 123 MAIN STREET ANYTOWN, NJ 01451 Phone: (999) 999-9999 Specimen ID: 111111111 Date of Report: 10/12/2013 8:02 AM Date Collected: 10/07/2013 Time Unknown Date Received: 10/09/2013 Source: RIGHT breast Clinical Information.

2 Right breast ReportDOCTORSAMPLE302 AUTOMATED breast cancer HER2/NEU fish ANALYSISACCT #:31C0079 JAGGESSARSINGH, DANA F:(718) 661-7745P:(718) 670-1374 NYH/QUEENS PATHOLOGY 56-45 MAIN STREET FLUSHING, NY 11355C,#F56Y11/19/1956 DOB:Age:Sex:Patient ID:3799708 FIN, ALICE 223 18 56 RDAddress:OAKLAND GARDENS, NY 11364 Phone:(718) 225-9190 Surgical #:S13-16145-1A Right breast carcinomaFixation time not provided. Specimen ID:302329051 Date of Report:10/17/2013 8:02 AMDate Collected:10/07/2013 Time UnknownDate Received:10/09/2013 Source:RIGHT BREASTC linical Information:Test DescriptionInterpretation and ResultsPhotomicrographNote relative predominance of red (HER2) signals compared to green (CEP-17) signals (x1000).

3 HER2 : CEP-17 ratio:Number of Cells Scanned:100 Average HER2 CEP-17 fish :1 HypodiploidMaximum HER2 fish results are best interpreted by analyzing the ratio with respect to the HER2/neu copy number. An H & E slide was reviewed and demonstrates lesional tissue. Analysis of HER2/neu gene amplification status was performed using an automated Fluorescence In Situ Hybridization ( fish ) signal enumeration system (Metafer Slide Scanning System, MetaSystems Group Inc., Watertown, MA). This system scans up to 5 different specified areas of tumor. A minimum of 20 cells representing >10% of contiguous and homogeneous invasive tumor cells were scanned.

4 * Negative/Not Amplified: HER2/CEP17 ratio of < with an average HER2 copy number of < signals/cell.* Equivocal/Borderline: HER2/CEP17 ratio of < with an average HER2 copy number of and < signals/cell.* Positive/Amplified: HER2/CEP17 ratio of with an average HER2 copy number of signals/cell, or HER2/CEP17 ratio of with an average HER2 copy number of < signals/cell, or HER2/CEP17 ratio of < with an average HER2 copy number of INFORMATIONREFERENCES2013 ASCO/CAP HER2 Testing Guideline update : Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in breast cancer .

5 Wolff, et al. Arch Pathol Lab Med. doi: HER2/neu DNA probe kit (Vysis) was used. This test was developed and its performance characteristics determined by Vysis. It has been approved by the FDA to detect the over-expression of the HER-2/neu gene in neoplastic breast tissue. It may help identify candidates for Herceptin therapy. This lab has been approved by CLIA 88, designated as a high complexity laboratory and is qualified to perform these tests. Results are reported using the ASCO/CAP scoring 1 of 1 Liliya Feldman, 10/17/2013 8:21 AMElectronically signed by J.

6 Weisberger, Laboratories, Edward H. Ross DriveElmwood Park, NJ 07407(800) 627-1479 James Weisberger, DirectorGenPath is a business unit of BioReference Laboratories, 10/12/2013481 Edward H Ross Drive Elmwood Park, NJ 07407 1 800 627 1479 tel 1 201 791 8760 fax GenPath is a business unit of BioReference Laboratories, Inc. 2013 BioReference Laboratories, Inc. All rights reserved. 91643 11/13 fish ReportFinal Report SMITH, SUSAN ONCOLOGY CENTER 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 F: 555-555-5555 DOCTORPATIENTSAMPLESAMPLE, REPORT DOB: 11/19/1956 Age: 56Y Sex: F Surgical #: XXXXXXXX Patient ID: 55555555 Address: 123 MAIN STREET ANYTOWN, NJ 01451 Phone: (999) 999-9999 Specimen ID: 111111111 Date of Report: 10/12/2013 8:02 AM Date Collected: 10/07/2013 Time Unknown Date Received: 10/09/2013 Source: RIGHT breast Clinical Information.

7 Right breast ReportDOCTORSAMPLE302 AUTOMATED breast cancer HER2/NEU fish ANALYSISACCT #:31C0079 JAGGESSARSINGH, DANA F:(718) 661-7745P:(718) 670-1374 NYH/QUEENS PATHOLOGY 56-45 MAIN STREET FLUSHING, NY 11355C,#F56Y11/19/1956 DOB:Age:Sex:Patient ID:3799708 FIN, ALICE 223 18 56 RDAddress:OAKLAND GARDENS, NY 11364 Phone:(718) 225-9190 Surgical #:S13-16145-1A Right breast carcinomaFixation time not provided. Specimen ID:302329051 Date of Report:10/17/2013 8:02 AMDate Collected:10/07/2013 Time UnknownDate Received:10/09/2013 Source:RIGHT BREASTC linical Information:Test DescriptionInterpretation and ResultsPhotomicrographNote relative predominance of red (HER2) signals compared to green (CEP-17) signals (x1000).

8 HER2 : CEP-17 ratio:Number of Cells Scanned:100 Average HER2 CEP-17 fish :1 HypodiploidMaximum HER2 fish results are best interpreted by analyzing the ratio with respect to the HER2/neu copy number. An H & E slide was reviewed and demonstrates lesional tissue. Analysis of HER2/neu gene amplification status was performed using an automated Fluorescence In Situ Hybridization ( fish ) signal enumeration system (Metafer Slide Scanning System, MetaSystems Group Inc., Watertown, MA). This system scans up to 5 different specified areas of tumor. A minimum of 20 cells representing >10% of contiguous and homogeneous invasive tumor cells were scanned.

9 * Negative/Not Amplified: HER2/CEP17 ratio of < with an average HER2 copy number of < signals/cell.* Equivocal/Borderline: HER2/CEP17 ratio of < with an average HER2 copy number of and < signals/cell.* Positive/Amplified: HER2/CEP17 ratio of with an average HER2 copy number of signals/cell, or HER2/CEP17 ratio of with an average HER2 copy number of < signals/cell, or HER2/CEP17 ratio of < with an average HER2 copy number of INFORMATIONREFERENCES2013 ASCO/CAP HER2 Testing Guideline update : Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in breast cancer .

10 Wolff, et al. Arch Pathol Lab Med. doi: HER2/neu DNA probe kit (Vysis) was used. This test was developed and its performance characteristics determined by Vysis. It has been approved by the FDA to detect the over-expression of the HER-2/neu gene in neoplastic breast tissue. It may help identify candidates for Herceptin therapy. This lab has been approved by CLIA 88, designated as a high complexity laboratory and is qualified to perform these tests. Results are reported using the ASCO/CAP scoring 1 of 1 Liliya Feldman, 10/17/2013 8:21 AMElectronically signed by J.